Back to top

Image: Bigstock

Aclaris Gets FDA Nod to Start Investigator-led Coronavirus Study

Read MoreHide Full Article

Aclaris Therapeutics, Inc. (ACRS - Free Report) announced that the FDA has allowed an investigational new drug application (IND) to evaluate its oral investigational MK2 inhibitor compound, ATI-450, in hospitalized patients with COVID-19, the disease caused by SARS-CoV-2.The companyis supporting an investigator-initiated phase II study of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19. The study, sponsored by the University of Kansas Medical Center,will evaluate the safety and efficacy of ATI-450 when used in addition to standard-of-care therapy.

The primary endpoint of the study is the proportion of subjects who are free from respiratory failure by day 14.

CRS leads to the release of multiple inflammatory cytokines,which precede acute respiratory distress syndrome, and is associated with significant morbidity and mortality in patients with COVID-19.

In a phase I study conducted inhealthy volunteers, ATI-450 targets the expression of inflammatory cytokines associated with CRS.Thus, the company believes that the candidatemay be an innovative approach to managing this disease.

Shares of the company went up 17% following the news. However, the shares of the company have lost 8.7% year to date compared with the industry’s decline of 6%.

Aclaris is also developing ATI-450 as a potential treatment for rheumatoid arthritis and other immuno-inflammatory diseases.

The company is currently developing its pipeline candidate A-101 45% topical solution for the treatment of common warts in two late-stage studies. The candidate met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts in both phase III studies of THWART-1 and THWART-2.

Apart from this, Aclaris has two JAK inhibitors, namely ATI-501 and ATI-502, in mid-stage development for treating alopecia. The company had in-licensed these two candidates from Rigel Pharmaceuticals, Inc, (RIGL - Free Report) in 2015. It has several other pre-clinical candidates in its portfolio.

 

Zacks Rank & Key Pick

Aclaris currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the same sector are Avenue Therapeutics Inc. (ATXI - Free Report) and Aldeyra Therapeutics Inc. (ALDX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Avenue’s loss per share estimates have narrowed from 75 cents to 59 cents for 2020 and from 91 cents to 86 cents for 2021 over the past 60 days.

Aldeyra’s loss per share estimates have narrowed from $1.92 to $1.46 for 2020 and from $2.10 to $1.59 for 2021 over the past 60 days.

Zacks’ Single Best Pick to Double

From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, SherazMian hand-picks one to have the most explosive upside of all. This young company’s gigantic growth was hidden by low-volume trading, then cut short by the coronavirus. But its digital products stand out in a region where the internet economy has tripled since 2015 and looks to triple again by 2025. Its stock price is already starting to resume its upward arc. The sky’s the limit! And the earlier you get in, the greater your potential gain.

Click Here, See It Free >>